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Kaftrio 75 mg / 50 mg / 100 mg film-coated tablets

Licence status
Authorised: 21/08/2020
Active substances
TEZACAFTOR, Ivacaftor, VX-445
Dosage Form
Film-coated tablet
Licence number
EU/1/20/1468/001
Licence holder
Vertex Pharmaceuticals (Ireland) Limited

Licence information

ATC code
R07AX32 ivacaftor, tezacaftor and elexacaftor
Legal supply status
Product subject to prescription which may not be renewed (A)
Place of sale
Supply through pharmacies only
Conditions of Licence
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing availability
Unknown
Advertising conditions
Advertising to healthcare professionals only
Licence issued
21/08/2020